NCT00136539

Neoadjuvant Therapy With Herceptin and Taxol for Breast Cancer

Neoadjuvant Therapy With Herceptin and Taxol for Stage II/III Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Harold J. Burstein, MD, PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the effectiveness and safety of administering Herceptin in combination with Taxol (paclitaxel) in the treatment of women with HER2-positive, early stage breast cancer prior to surgery.

Detailed description

Patients will receive Herceptin intravenously once weekly for 12 weeks, and Taxol intravenously every 3 weeks (week 1, week 4, week 7 and week 10). After 12 weeks of treatment, breast surgery will be performed (either a lumpectomy or a mastectomy). Once patients have recovered from the surgery, they will receive adriamycin and cytoxan every 3 weeks for 4 cycles (12 weeks total). After Herceptin and Taxol therapy, tumor assessment will be performed along with an echocardiogram and mammogram. At the time of surgery, re-assessment of the tumor will be done. Blood work will be performed on day one of each chemotherapy cycle.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Herceptin	Given intravenously once weekly for 12 weeks prior to surgery.
DRUG	Taxol	Given intravenously every 3 weeks (weeks 1, 4, 7, and 10) before surgery.
DRUG	Adriamycin	Given every three weeks for 12 weeks after surgery.
DRUG	Cytoxan	Given every three weeks for 12 weeks after surgery.

Timeline

• Start date: 1999-03-01
• Primary completion: 2006-11-01
• Completion: 2012-03-01
• First posted: 2005-08-29
• Last updated: 2013-02-18

Locations

2 sites across 1 country: United States